Z-1320-2015Class III

cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay

Name: Z-1320-2015 cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Creator: Roche Molecular Systems, Inc.
Published: 2015-01-13
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2015-01-13 / Terminated

FDA source

Roche Molecular Systems, Inc. began a recall of cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay on 2015-01-13. FDA classified it as Class III and gives the reason as "False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1320-2015
Classification: Class III
Status: Terminated
Initiated: 2015-01-13
Posted: 2015-03-25
Terminated: 2017-12-11
Recalling firm: Roche Molecular Systems Inc
Product: cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Product code: OWD Somatic Gene Mutation Detection System
Reason for recall: False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.
FDA root cause: Under Investigation by firm
Action: RMS notified their customers on 1/13/2015.
Quantity in commerce: 190 kits
Distribution: Foreign
Product codes and lots: T08661

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1320-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1320-2015	Class III	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-25

Product code OWD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)